Effect of Fenofibrate on Sleep Apnea Syndrome

Obesity Clinical Trial

Official title:

A 1-month, Randomized, Double-blind, Placebo-controlled Study of Fenofibrate 145 mg Tablet in Patients With Sleep Apnea Syndrome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00816829
• Other study ID #: C LF178P 05 01
• Secondary ID: 2005-000548-98
• Status: Terminated
• Phase: Phase 2
• First received: January 2, 2009
• Last updated: July 17, 2009
• Start date: September 2005
• Est. completion date: January 2008

Study information

• Verified date: July 2009
• Source: Solvay Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

Objectives: to investigate for the potential effect of fenofibrate on symptoms and biological changes associated with sleep apnea syndrome.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Having previous diagnosis of sleep apnea not treated with Continuous Positive Airway Pressure (CPAP) or presenting clinical symptoms of sleep apnea

• Overweight or obese, with BMI >= 25 kg/m² and < 40 kg/m².

• Known moderate hypertriglyceridemia, with fasting Triglycerides level >= 2.0 and < 6.0 mmol/L within 3 months before the inclusion.

Exclusion Criteria:

• indication for immediate CPAP

• other known endocrine disease, except treated and adequately controlled hypothyroidism

• renal failure or plasma creatinine level >130 µmol/L

• current chronic liver disease or ALanine Amino Transferase (ALT)> 2 times the upper normal limit (UNL)

• symptomatic gallbladder disease

• known muscular disease or creatine phosphokinase (CK) > 3 times UNL.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Dyslipidemia
• Dyslipidemias
• Obesity
• Overweight
• Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Syndrome

Intervention

Drug:
• Placebo
Fenofibrate-matching placebo tablet
• Fenofibrate
145 mg NanoCrystal tablet

Locations

Country	Name	City	State
France	Site 1	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Solvay Pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Obstructive Apneas		at one month of treatment	No
Primary	Desaturations		at one month of treatment	No
Primary	Sleep Time With Oxygen Saturation Below 90%		at one month of treatment	No
Primary	Apneas		at one month of treatment	No
Primary	Hypopneas		at one month of treatment	No
Primary	Index Apnea/Hypopnea		at one month of treatment	No
Primary	Mixed Apneas		at one month of treatment	No
Primary	Central Apneas		at one month of treatment	No
Primary	Index of Apneas		at one month of treatment	No
Primary	Index of Hypopneas		at one month of treatment	No